Clinical trial · Interventional
Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer
A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
NCT03583580CI-TRIAL-00111999active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Recurrence, Local | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated Partial Breast Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Accelerated Partial Breast Irradiation
- description
- Accelerated partial breast irradiation (APBI) to the region of tumour bed
- interventionNames
- Radiation: Accelerated Partial Breast Irradiation
Primary outcomes (1)
- measure
- locoregional control rate
- timeFrame
- 5 years
- description
- ipsilateral breast and axilla nodal relapse rate
Secondary outcomes (3)
- measure
- overall survival
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Life Expectation: \> 5 years * Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy * Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade * Unifocal tumour (confirmed by diagnostic MRI) * No lymphovascular invasion * ER positive (defined as medium-strongly nuclear staining in \>1% of the cancer cells) * Negative radial resection margins of \>= 2 mm * Surgical clips placed in the tumor bed * Written informed consent. Exclusion Criteria: * Stage Ⅱ-Ⅲ * Multifocal tumors * Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma * Paget's disease of the nipple * Underwent oncoplastic surgery of ipsilateral breast * Underwent neoadjuvant chemotherapy or hormonal therapy * Previous or simultaneous contralateral breast cancer * Undergone ipsilateral chest wall radiotherapy * Active collagen vascular disease.
References
Publications (0)
Data not yet available
No reference posted for this study.